Cardiac ArrhythmiaNCT04727645
Use of "iSuite" During CMR-guided Electrophysiological Procedures
An observational study of Cardiac Arrhythmia, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
Trial summary
The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "iSuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-guided electrophysiological procedure (CMR-EP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- 4 Jan 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include all eligible patients who are already scheduled and thus eligible for CMR-guided electrophysiological procedure for the treatment of a cardiac rhythm disturbance in the MUMC+, albeit meeting the in- and exclusion criteria.
Who may be able to join
- Already scheduled by the treating electrophysiologist for CMR-EP as standard care for the treatment of a cardiac arrhythmia.
- Minimum age of 18 years old.
- Written informed consent
Who cannot join
- Participation in another investigational study that has not reached its primary endpoint.
- Contraindication for MRI such as: metallic implant, body weight > 130 kg, pregnancy, breast feeding women, known severe allergy to gadolineum contrast agents, renal failure with eGFR ≤ 30 mL/min/1,73m2.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht UMC+
Maastricht, Limburg, 6202 AZ
K Vernooy, Prof. dr.
G.P Bijvoet, MD
About this study
Official title: Prospective Use of Philips "iSuite" Electroanatomical Mapping System in Addition to Standard CMR-guided Electrophysiological Procedures
The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "iSuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-guided electrophysiological procedure (CMR-EP).
- Conditions
- Cardiac Arrhythmia
- Being tested
- Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)
- Keywords
- Cardiac Magnetic Resonance Imaging (CMR), CMR-guided electrophysiological procedure, Radiofrequency ablation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)Other
Also called "iSuite"
iSuite is an an electroanatomical mapping system (EAM) designed to support real-time MRI guided interventional procedures.
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP
To establish whether the visualization by iSuite is correct we will compare the location visualized by the EAM with the reference images as produced by the default cine MRI sequences at the target ablation location just prior to the RF ablation. The definition of correct visualization is: good agreement between the two modalities (EAM and cine MRI) based on visual assessment of the treating electrophysiologist and the supervising CMR expert. When no consensus is reached than the visualization is coded 'incorrect'. This outcome will be dichotomized and coded as 'correct visualization' or 'incorrect visualization'. This categorical variable will be expressed as counts and proportion with 95% confidence interval (CI).
Measured: Periprocedural
Secondary outcomes (3)
Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure:
Anatomical confirmation of a complete ablation lesion is defined as a continuous line of high signal intensity at the target location on the edema and fibrosis sequences of the CMR at the end of the procedure. This anatomical confirmation will be judged by the CMR expert that is present during the procedure and thus will not be blinded to the EP results. Procedural success and procedural complications will be reported as count and proportion with 95% CI.
Measured: Periprocedural
Procedural time
To investigate the procedure-by-procedure change in procedural times and total amount of CMR images needed until application of the first ablation lesion
Measured: Periprocedural
Complication rate
To investigate the complication rate of CMR-EP with the integration of iSuite.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start4 Jan 2021
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Ziekenhuis Maastricht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.M. Chaldoupi, Academisch Ziekenhuis Maastricht
- Investigators
- S.M. Chaldoupi, Principal investigator, Maastricht UMCCasper Mihl, Principal investigator, Maastricht UMCJ.E Wildberger, Prof. Dr, Study chair, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727645
- Sponsor's protocol ID
- NL74812.068.20
- Other IDs
- METC20-064
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2021
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a small scale single center study and there is no plan to share IPD in order to ensure participant privacy, and the risk of invalid analysis. Data will be registered in the Castor EDC database by the investigator, after patient data has been anonymized. The principal investigator and involved investigators of the research team will have access to the source data and safeguard the code. The handling of personal data will comply with the General Data Protection Regulation and the Dutch Act on Implementation of the General Protection Regulation. Data and the key to the unique patient study number will be kept for 15 years after study end. During this single centre study, no data will be shared or transferred. Once the study has ended, we will ensure that all data are managed and securely stored. Data will be available for use in future research on cardiac arrhythmia. Qualified monitors of Clinical Trial Centre Maastricht will independently perform monitoring of the study.
Publications
Hilbert S, Sommer P, Gutberlet M, Gaspar T, Foldyna B, Piorkowski C, Weiss S, Lloyd T, Schnackenburg B, Krueger S, Fleiter C, Paetsch I, Jahnke C, Hindricks G, Grothoff M. Real-time magnetic resonance-guided ablation of typical right atrial flutter using a combination of active catheter tracking and passive catheter visualization in man: initial results from a consecutive patient series. Europace. 2016 Apr;18(4):572-7. doi: 10.1093/europace/euv249. Epub 2015 Aug 27.
PubMed 26316146Paetsch I, Sommer P, Jahnke C, Hilbert S, Loebe S, Schoene K, Oebel S, Krueger S, Weiss S, Smink J, Lloyd T, Hindricks G. Clinical workflow and applicability of electrophysiological cardiovascular magnetic resonance-guided radiofrequency ablation of isthmus-dependent atrial flutter. Eur Heart J Cardiovasc Imaging. 2019 Feb 1;20(2):147-156. doi: 10.1093/ehjci/jey143.
PubMed 30307544Vergara GR, Vijayakumar S, Kholmovski EG, Blauer JJ, Guttman MA, Gloschat C, Payne G, Vij K, Akoum NW, Daccarett M, McGann CJ, Macleod RS, Marrouche NF. Real-time magnetic resonance imaging-guided radiofrequency atrial ablation and visualization of lesion formation at 3 Tesla. Heart Rhythm. 2011 Feb;8(2):295-303. doi: 10.1016/j.hrthm.2010.10.032. Epub 2010 Oct 27.
PubMed 21034854Lichter J, Kholmovski EG, Coulombe N, Ghafoori E, Kamali R, MacLeod R, Ranjan R. Real-time magnetic resonance imaging-guided cryoablation of the pulmonary veins with acute freeze-zone and chronic lesion assessment. Europace. 2019 Jan 1;21(1):154-162. doi: 10.1093/europace/euy089.
PubMed 29878090
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Use of Philips "iSuite" Electroanatomical Mapping System in Addition to Standard CMR-guided Electrophysiological Procedures
- ClinicalTrials.gov ID
- NCT04727645
- Acronym / sponsor ID
- NL74812.068.20
- Conditions
- Cardiac Arrhythmia
- Keywords
- Cardiac Magnetic Resonance Imaging (CMR), CMR-guided electrophysiological procedure, Radiofrequency ablation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Academisch Ziekenhuis MaastrichtUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The perpuse of this study is to investigate the feasibility of the Philips interventional MRI suite "iSuite" to create an electroanatomical map of the heart based on which the real-time location of the catheters can be correctly and reliably visualized during CMR-guided electrophysiological procedure (CMR-EP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include all eligible patients who are already scheduled and thus eligible for CMR-guided electrophysiological procedure for the treatment of a cardiac rhythm disturbance in the MUMC+, albeit meeting the in- and exclusion criteria.
Key inclusion criteria (3 listed)
- Already scheduled by the treating electrophysiologist for CMR-EP as standard care for the treatment of a cardiac arrhythmia.
- Minimum age of 18 years old.
- Written informed consent
Key exclusion criteria (2 listed)
- Participation in another investigational study that has not reached its primary endpoint.
- Contraindication for MRI such as: metallic implant, body weight > 130 kg, pregnancy, breast feeding women, known severe allergy to gadolineum contrast agents, renal failure with eGFR ≤ 30 mL/min/1,73m2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)Also: "iSuite"iSuite is an an electroanatomical mapping system (EAM) designed to support real-time MRI guided interventional procedures. | Other | – |
Primary outcome
The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP
Time frame: Periprocedural
To establish whether the visualization by iSuite is correct we will compare the location visualized by the EAM with the reference images as produced by the default cine MRI sequences at the target ablation location just prior to the RF ablation. The definition of correct visualization is: good agreement between the two modalities (EAM and cine MRI) based on visual assessment of the treating electrophysiologist and the supervising CMR expert. When no consensus is reached than the visualization is coded 'incorrect'. This outcome will be dichotomized and coded as 'correct visualization' or 'incorrect visualization'. This categorical variable will be expressed as counts and proportion with 95% confidence interval (CI).
3 secondary outcomes
Procedural success as measured by electrical and anatomical confirmation of a complete ablation lesion at the end of the procedure:
Time frame: Periprocedural
Procedural time
Time frame: Periprocedural
Complication rate
Time frame: Periprocedural
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Background: PubMed 26316146Hilbert S, Sommer P, Gutberlet M, Gaspar T, Foldyna B, Piorkowski C, Weiss S, Lloyd T, Schnackenburg B, Krueger S, Fleiter C, Paetsch I, Jahnke C, Hindricks G, Grothoff M. Real-time magnetic resonance-guided ablation of typical right atrial flutter using a combination of active catheter tracking and passive catheter visualization in man: initial results from a consecutive patient series. Europace. 2016 Apr;18(4):572-7. doi: 10.1093/europace/euv249. Epub 2015 Aug 27.
- Background: PubMed 30307544Paetsch I, Sommer P, Jahnke C, Hilbert S, Loebe S, Schoene K, Oebel S, Krueger S, Weiss S, Smink J, Lloyd T, Hindricks G. Clinical workflow and applicability of electrophysiological cardiovascular magnetic resonance-guided radiofrequency ablation of isthmus-dependent atrial flutter. Eur Heart J Cardiovasc Imaging. 2019 Feb 1;20(2):147-156. doi: 10.1093/ehjci/jey143.
- Background: PubMed 21034854Vergara GR, Vijayakumar S, Kholmovski EG, Blauer JJ, Guttman MA, Gloschat C, Payne G, Vij K, Akoum NW, Daccarett M, McGann CJ, Macleod RS, Marrouche NF. Real-time magnetic resonance imaging-guided radiofrequency atrial ablation and visualization of lesion formation at 3 Tesla. Heart Rhythm. 2011 Feb;8(2):295-303. doi: 10.1016/j.hrthm.2010.10.032. Epub 2010 Oct 27.
- Background: PubMed 29878090Lichter J, Kholmovski EG, Coulombe N, Ghafoori E, Kamali R, MacLeod R, Ranjan R. Real-time magnetic resonance imaging-guided cryoablation of the pulmonary veins with acute freeze-zone and chronic lesion assessment. Europace. 2019 Jan 1;21(1):154-162. doi: 10.1093/europace/euy089.
- Individual participant dataSharing planned: No. This is a small scale single center study and there is no plan to share IPD in order to ensure participant privacy, and the risk of invalid analysis. Data will be registered in the Castor EDC database by the investigator, after patient data has been anonymized. The principal investigator and involved investigators of the research team will have access to the source data and safeguard the code. The handling of personal data will comply with the General Data Protection Regulation and the Dutch Act on Implementation of the General Protection Regulation. Data and the key to the unique patient study number will be kept for 15 years after study end. During this single centre study, no data will be shared or transferred. Once the study has ended, we will ensure that all data are managed and securely stored. Data will be available for use in future research on cardiac arrhythmia. Qualified monitors of Clinical Trial Centre Maastricht will independently perform monitoring of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
S.M. Chaldoupi principal investigator
Maastricht UMC
Casper Mihl principal investigator
Maastricht UMC
J.E Wildberger, Prof. Dr study chair
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Academisch Ziekenhuis Maastricht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marisevi Chaldoupi (+31 43 387 7223, marisevi.chaldoupi@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The feasibility of iSuite to create an electroanatomical map (EAM) of the heart during CMR-EP (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04727645, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.